SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002900
Collaborator
National Cancer Institute (NCI) (NIH)
180
105
1.7
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in treating women who have breast cancer with negative axillary lymph nodes and who are undergoing treatment on the SWOG-8897 clinical trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
-
Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin, and fluorouracil on protocol SWOG-8897.
-
Estimate the frequency of late cardiac effects (congestive heart failure, cardiac ischemic events, and clinical symptoms) in these patients treated with these regimens.
-
Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens.
OUTLINE: This is a multicenter study.
The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897. The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study, and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study.
PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial accrual is completed, approximately 50 additional patients will be accrued at 10 years.
Study Design
Study Type:
Observational
Actual Enrollment
:
180 participants
Time Perspective:
Prospective
Official Title:
A STUDY OF THE LATE CARDIAC EFFECTS OF TWO DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENTS IN WOMEN WITH NODE NEGATIVE BREAST CANCER TREATED ON SWOG-8897
Study Start Date
:
Feb 1, 1997
Actual Primary Completion Date
:
Mar 1, 2008
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 120 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Women registered on Arm I, II, III, or IV of protocol SWOG-8897 who have completed at least 1 course of assigned chemotherapy
-
Completion of tamoxifen therapy not required
-
Registration to current study required between 5.25-8 years or 10-11 years after randomization to protocol SWOG-8897
-
Patients must be diagnosed disease-free with no prior recurrence after registration on protocol SWOG-8897
-
Hormone receptor status:
-
Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Pre- and postmenopausal
Performance status:
- Not specified
Life Expectancy:
- At least 5 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
-
Pregnant or nursing women not eligible for nuclear medicine (MUGA) portion of study
-
Fertile patients must use effective contraception during and for 1 month after MUGA
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
-
See Disease Characteristics
-
No prior chemotherapy for second primary malignancy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for second primary malignancy
Surgery:
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36688 |
| 2 | CCOP - Western Regional, Arizona | Phoenix | Arizona | United States | 85006-2726 |
| 3 | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | United States | 85012 |
| 4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
| 5 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
| 8 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 9 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 10 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
| 11 | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | United States | 90073 |
| 12 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 13 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
| 14 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 15 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 16 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 17 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94143-0128 |
| 18 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 19 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 20 | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | United States | 80010 |
| 21 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
| 22 | MBCCOP - Howard University Cancer Center | Washington | District of Columbia | United States | 20060 |
| 23 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 24 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
| 25 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813-2424 |
| 26 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 27 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
| 28 | MBCCOP - University of Illinois at Chicago | Chicago | Illinois | United States | 60612-7323 |
| 29 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
| 30 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 31 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
| 32 | Loyola University Medical Center | Maywood | Illinois | United States | 60153-5500 |
| 33 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7353 |
| 34 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 35 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
| 36 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40502-2236 |
| 37 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 38 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 39 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 40 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 41 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
| 42 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 43 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
| 44 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
| 45 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
| 46 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0912 |
| 47 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 48 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
| 49 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 50 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
| 51 | CCOP - Beaumont | Royal Oak | Michigan | United States | 48073-6769 |
| 52 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
| 53 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 54 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
| 55 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 56 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
| 57 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
| 58 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 59 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110 |
| 60 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
| 61 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 62 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 63 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
| 64 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
| 65 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
| 66 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
| 67 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 68 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
| 69 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
| 70 | Barrett Cancer Center | Cincinnati | Ohio | United States | 45267-0501 |
| 71 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-9001 |
| 72 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 73 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 74 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
| 75 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43623-3456 |
| 76 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 77 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 78 | Oregon Cancer Institute | Portland | Oregon | United States | 97201-3098 |
| 79 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
| 80 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
| 81 | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | United States | 29401-5799 |
| 82 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 83 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 84 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 85 | University of Tennessee Cancer Institute | Memphis | Tennessee | United States | 38103 |
| 86 | Danville Radiation Therapy Center | Memphis | Tennessee | United States | 38104 |
| 87 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 88 | Veterans Affairs Medical Center - Amarillo | Amarillo | Texas | United States | 79106 |
| 89 | Veterans Affairs Medical Center - Dallas | Dallas | Texas | United States | 75216 |
| 90 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234-6200 |
| 91 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 92 | Veterans Affairs Medical Center - Houston | Houston | Texas | United States | 77030 |
| 93 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
| 94 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78229 |
| 95 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
| 96 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 97 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112-5550 |
| 98 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 99 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 100 | MBCCOP - Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 101 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 102 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98104 |
| 103 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
| 104 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
| 105 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-5000 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Patricia A. Ganz, MD, Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002900
Other Study ID Numbers:
- CDR0000065237
- U10CA032102
- SWOG-9342
First Posted:
Jan 27, 2003
Last Update Posted:
Oct 19, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: